PA21 Phase II Clinical Study in Hemodialysis Patients With Hyperphosphatemia

• Sponsor: Kissei Pharmaceutical Co., Ltd. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01521494
• Collaborator: (none)
• Enrollment: 183
• Location: 1
• Arms: 5
• Actual Duration (Months): 5.7
• Patients Per Site Per Month: 32

Study Details

Study Description

Brief Summary

To investigate dose-response efficacy and safety in hemodialysis patients with hyperphosphatemia.

Condition or Disease	Intervention/Treatment	Phase
Chronic Kidney Disease Requiring Hemodialysis	Drug: PA21; Drug: PA21; Drug: PA21; Drug: PA21; Drug: Placebo	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 183 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double
• Primary Purpose: Treatment
• Actual Study Start Date: Jan 11, 2012
• Actual Primary Completion Date: Jul 3, 2012
• Actual Study Completion Date: Jul 3, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: PA21 750 mg/day	Drug: PA21
Experimental: PA21 1500 mg/day	Drug: PA21
Experimental: PA21 2250 mg/day	Drug: PA21
Experimental: PA21 3000 mg/day	Drug: PA21
Placebo Comparator: Placebo	Drug: Placebo

Outcome Measures

Primary Outcome Measures

1. Change From Baseline in Serum Phosphorus Concentrations at the End of Treatment. [6 weeks]

   Changes in serum phosphorus concentrations from baseline to the end of treatment were adjusted by serum phosphorus concentration at baseline.

Secondary Outcome Measures

1. Change From Baseline in Serum Calcium Concentrations. [6 weeks]

2. Change From Baseline in Serum Intact-PTH Concentrations. [6 weeks]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Patients age 20 or older, regardless of gender.

• Receiving stable maintenance hemodialysis 3 times a week.

• Patients not having changed their phosphate binder agent dose, for 4 weeks or more before their observation period start.

Exclusion Criteria:

• Patients having history of a pronounced brain / cardiovascular disorder.

• Patients having severe gastrointestinal disorders.

• Patients having severe hepatic disorders.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Japan	Multiple Locations		Japan

Sponsors and Collaborators

• Kissei Pharmaceutical Co., Ltd.

Investigators

• Study Director: Tatsuro Takei, Clinical Development Department, Kissei pharmaceutical Co., Ltd.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Kissei Pharmaceutical Co., Ltd.
• ClinicalTrials.gov Identifier: NCT01521494
• Other Study ID Numbers: PA1201
• First Posted: Jan 30, 2012
• Last Update Posted: Aug 23, 2018
• Last Verified: Nov 1, 2017

• Keywords provided by Kissei Pharmaceutical Co., Ltd.: Hemodialysis; Hyperphosphatemia
• Additional relevant MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic; Hyperphosphatemia

Study Results

Participant Flow

Arm/Group Title	PA21 750 mg/Day	PA21 1500 mg/Day	PA21 2250 mg/Day	PA21 3000 mg/Day	Placebo
Arm/Group Description	PA21	PA21	PA21	PA21	Placebo
Period Title: Overall Study
STARTED	39	36	35	36	37
COMPLETED	37	31	23	15	30
NOT COMPLETED	2	5	12	21	7

Baseline Characteristics

Arm/Group Title	PA21 750 mg/Day	PA21 1500 mg/Day	PA21 2250 mg/Day	PA21 3000 mg/Day	Placebo	Total
Arm/Group Description	PA21	PA21	PA21	PA21	Placebo	Total of all reporting groups
Overall Participants	39	35	33	34	37	178
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	59.4 (10.4)	63.8 (12.0)	61.9 (10.5)	61.4 (11.2)	60.8 (10.2)	61.4 (10.9)
Sex: Female, Male (Count of Participants)
Female	12 30.8%	12 34.3%	10 30.3%	15 44.1%	14 37.8%	63 35.4%
Male	27 69.2%	23 65.7%	23 69.7%	19 55.9%	23 62.2%	115 64.6%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Asian	39 100%	35 100%	33 100%	34 100%	37 100%	178 100%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Black or African American	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
White	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
More than one race	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Unknown or Not Reported	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Dialysis vintage (months) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [months]	77.6 (67.5)	85.1 (60.7)	95.8 (81.9)	91.5 (58.6)	71.0 (45.0)	83.7 (63.5)

Outcome Measures

1. Primary Outcome

Title	Change From Baseline in Serum Phosphorus Concentrations at the End of Treatment.
Description	Changes in serum phosphorus concentrations from baseline to the end of treatment were adjusted by serum phosphorus concentration at baseline.
Time Frame	6 weeks

Outcome Measure Data

Analysis Population Description

Total of 5 patients were excluded from analysis because they failed to have primary endpoint.

Arm/Group Title	PA21 750 mg/Day	PA21 1500 mg/Day	PA21 2250 mg/Day	PA21 3000 mg/Day	Placebo
Arm/Group Description	PA21	PA21	PA21	PA21	Placebo
Measure Participants	39	35	33	34	37
Least Squares Mean (95% Confidence Interval) [mg/dL]	-1.84	-2.59	-3.17	-3.78	0.14

2. Secondary Outcome

Title	Change From Baseline in Serum Calcium Concentrations.
Time Frame	6 weeks

Outcome Measure Data

Analysis Population Description

Total of 5 patients were excluded from analysis because they failed to have primary endpoint.

Arm/Group Title	PA21 750 mg/Day	PA21 1500 mg/Day	PA21 2250 mg/Day	PA21 3000 mg/Day	Placebo
Arm/Group Description	PA21	PA21	PA21	PA21	Placebo
Measure Participants	39	35	33	34	37
Mean (Standard Deviation) [mg/dL]	0.20 (0.34)	0.16 (0.33)	0.38 (0.44)	0.38 (0.39)	-0.09 (0.31)

3. Secondary Outcome

Title	Change From Baseline in Serum Intact-PTH Concentrations.
Time Frame	6 weeks

Outcome Measure Data

Analysis Population Description

Some patients were excluded from analysis because they failed to have primary endpoint or missed to measure intact-PTH at the end of treatment.

Arm/Group Title	PA21 750 mg/Day	PA21 1500 mg/Day	PA21 2250 mg/Day	PA21 3000 mg/Day	Placebo
Arm/Group Description	PA21	PA21	PA21	PA21	Placebo
Measure Participants	39	34	31	31	37
Mean (Standard Deviation) [pg/mL]	-35.2 (89.8)	-45.6 (79.2)	-97.0 (92.7)	-86.5 (104.0)	21.5 (82.5)

Adverse Events

Time Frame	6 weeks
Arm/Group Title	PA21 750 mg/Day		PA21 1500 mg/Day		PA21 2250 mg/Day		PA21 3000 mg/Day		Placebo
Arm/Group Description	PA21		PA21		PA21		PA21		Placebo
All Cause Mortality
	PA21 750 mg/Day		PA21 1500 mg/Day		PA21 2250 mg/Day		PA21 3000 mg/Day		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/39 (0%)		0/36 (0%)		0/35 (0%)		0/36 (0%)		0/37 (0%)
Serious Adverse Events
	PA21 750 mg/Day		PA21 1500 mg/Day		PA21 2250 mg/Day		PA21 3000 mg/Day		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/39 (2.6%)		2/36 (5.6%)		2/35 (5.7%)		1/36 (2.8%)		1/37 (2.7%)
Cardiac disorders
Angina pectoris	0/39 (0%)		0/36 (0%)		0/35 (0%)		1/36 (2.8%)		0/37 (0%)
Cardiac failure congestive	1/39 (2.6%)		0/36 (0%)		0/35 (0%)		0/36 (0%)		0/37 (0%)
Infections and infestations
Liver abscess	0/39 (0%)		1/36 (2.8%)		0/35 (0%)		0/36 (0%)		0/37 (0%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer	0/39 (0%)		1/36 (2.8%)		0/35 (0%)		0/36 (0%)		0/37 (0%)
Nervous system disorders
Brain stem infarction	0/39 (0%)		0/36 (0%)		1/35 (2.9%)		0/36 (0%)		0/37 (0%)
Cerebral infarction	1/39 (2.6%)		0/36 (0%)		0/35 (0%)		0/36 (0%)		0/37 (0%)
Intracranial aneurysm	0/39 (0%)		0/36 (0%)		1/35 (2.9%)		0/36 (0%)		0/37 (0%)
Vascular disorders
Peripheral arterial occlusive disease	0/39 (0%)		0/36 (0%)		0/35 (0%)		0/36 (0%)		1/37 (2.7%)
Other (Not Including Serious) Adverse Events
	PA21 750 mg/Day		PA21 1500 mg/Day		PA21 2250 mg/Day		PA21 3000 mg/Day		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	13/39 (33.3%)		11/36 (30.6%)		19/35 (54.3%)		20/36 (55.6%)		11/37 (29.7%)
Gastrointestinal disorders
Abdominal pain	0/39 (0%)		0/36 (0%)		0/35 (0%)		2/36 (5.6%)		0/37 (0%)
Constipation	0/39 (0%)		1/36 (2.8%)		2/35 (5.7%)		2/36 (5.6%)		1/37 (2.7%)
Diarrhoea	6/39 (15.4%)		6/36 (16.7%)		13/35 (37.1%)		15/36 (41.7%)		7/37 (18.9%)
Flatulence	0/39 (0%)		0/36 (0%)		0/35 (0%)		1/36 (2.8%)		2/37 (5.4%)
Haemorrhoids	0/39 (0%)		0/36 (0%)		2/35 (5.7%)		0/36 (0%)		0/37 (0%)
Infections and infestations
Nasopharyngitis	5/39 (12.8%)		5/36 (13.9%)		3/35 (8.6%)		3/36 (8.3%)		4/37 (10.8%)
Injury, poisoning and procedural complications
Contusion	0/39 (0%)		0/36 (0%)		0/35 (0%)		4/36 (11.1%)		0/37 (0%)
Musculoskeletal and connective tissue disorders
Pain in extremity	0/39 (0%)		1/36 (2.8%)		2/35 (5.7%)		0/36 (0%)		0/37 (0%)
Psychiatric disorders
Insomnia	2/39 (5.1%)		0/36 (0%)		0/35 (0%)		0/36 (0%)		0/37 (0%)
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract inflammation	2/39 (5.1%)		0/36 (0%)		0/35 (0%)		0/36 (0%)		0/37 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.